Imbruvica® (ibrutinib) Approved by U.S. FDA for the First-Line Treatment of Chronic Lymphocytic Leukemia

Imbruvica® (ibrutinib) Approved by U.S. FDA for the First-Line Treatment of Chronic Lymphocytic Leukemia

March 4, 2016 – The U.S. Food and Drug Administration approved Imbruvica® (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL). The approval is based on data from the randomized, multi-center, open-label Phase 3 RESONATE™-2 (PCYC-1115) trial, which evaluated the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. The RESONATE-2 data were previously presented at the American Society of Hematology (ASH) Annual Meeting in December 2015 and also simultaneously published in The New England Journal of Medicine. This approval represents the first FDA-approved chemotherapy-free treatment option for first-line treatment for CLL patients. Imbruvica is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company and Janssen Biotech, Inc.